FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AlloX2 Magnetic Site Locator
DI: M746AMSL010
·
Model: AMSL01
·
SPECIALTY SURGICAL PRODUCTS INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- AlloX2 Magnetic Site Locator
- Primary DI
- M746AMSL010
- Version / Model
- AMSL01
- Catalog Number
- AMSL01
- Company Name
- SPECIALTY SURGICAL PRODUCTS INC
- Labeler DUNS
- 002112626
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-15
- Public Version
- 3
- Public Version Date
- 2018-05-02
- Public Version Status
- Update
- Public Device Record Key
- 40e021ba-246d-4a28-8e13-5ba1ff6239dd
- Distribution End Date
- 2016-11-11
Device Description
AlloX2 Magnetic Site Locator For Use with SSP AlloX2 Magnetic Injection & Drain Ports
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LCJ | Expander, Skin, Inflatable | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46583 | Tissue expander injection port locator | A small, hand-held, manually-operated, sterile device designed to assist with the location of the subcutaneous injection port of an implanted tissue expander prior to the insertion of a filling needle into the port in order to fill the tissue expander with, e.g., saline. It is moved over the surface of the skin at the point where the concealed injection site is situated and an indicator, e.g., a small magnet, reacts to the metal material of the port, indicating where it is located. Repetition of this locating process on several axes provides the exact location of the injection site. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M746AMSL011 | HIBCC | Box | 5 | Not in Commercial Distribution | 2016-11-11 |
| Primary | M746AMSL010 | HIBCC |
Customer Contacts
- Phone
- 888-878-0811
- [email protected]